Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of a self-etch adhesive using a selective etch technique

Conditions: Dental Caries

Summary: study hypothesis: etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.

there is scant evidence available on the performance of self-etching dental adhesive systems. this study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.

Eligibility criteria:
inclusion criteria: * 18 years or older * written informed consent * regular dental attender, can return to clinic for study recalls * good medical health * normal saliva flow * has one or two pairs of back teeth that require a class i or ii restoration of appropriate size * study teeth that are vital exclusion criteria: * currently in an evaluation of other dental materials * an irregular dental attender * has unacceptable oral hygiene standards * has chronic periodontitis or rampant caries * has teeth with signs of periapical pathology * has history of pulp problems, and/or needs pulp treatment * women who are pregnant or breast-feeding * has known allergy to resin composite or latex * has serious chronic disease requiring hospitalization * has oral soft tissue pathologies * takes medications which, in the opinion of the investigator, could interfere with the conduct of the study * has current or recent history of alcohol or other substance abuse * is an employee of the sponsor or the study site, or members of their immediate family * has had any restorative treatment of teeth involved in the study in the last twelve months

Keywords: self-etch adhesive selective enamel etching adper easy bond supreme ultra molar and premolar teeth adult class i and ii cavities
effects of intravenous infusions of gut hormones on appetite and metabolism.

Conditions: Obesity

Summary: the purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, pyy3-36 and glp-1, alone and in combination, on appetite in healthy obese men. the investigators hypothesize that an intravenous infusion of each hormone alone will decrease food intake at a buffet meal and decrease appetite, and that in combination, there will be a greater decrease in food intake and appetite compared to each hormone alone.


Eligibility criteria:
inclusion criteria: * men age 18-50 years * bmi ≥30 * healthy exclusion criteria: * diabetes mellitus * psychological illness * on special diets (eg vegetarian, atkins) * weight change of \>3kg within the 2 months prior to screening * hypothalamic or genetic aetiology of obesity * diagnosed cancer * chronic illness or disease * eating disorder (anorexia or bulimia) * smoking * substance abuse * use of any prescription or over the counter medication that can affect metabolism * excessive intake of alcohol (\>7 drinks/week) * excessive intake of caffeine (\>300 mg/day) * high level of physical activity (\>10 hours/week) * lack of desire or willingness to take part in and follow study protocol

Keywords: obesity energy expenditure incretins appetite regulation glp-1 pyy ad libitum energy intake
hiv attachment inhibitor to treat human immunodeficiency virus 1 (hiv-1) infections

Conditions: Infection, Human Immunodeficiency Virus

Summary: the purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of bms-663068 with raltegravir (ral) + tenofovir disoproxil fumarate (tdf). at least 1 dose of bms-663068 can be identified which is safe, well tolerated, and efficacious when combined with ral + tdf for treatment-experienced hiv-1 infected subjects. phenosense® is a registered trademark of monogram biosciences.

masking: double-blind for bms-6630368 treatment groups until the week 24 primary endpoint analysis, then open label. the reference groups is all open-label. arms: 5 (4 bms-663068 treatment groups and 1 reference group) intervention model: parallel (with unblinding after the week 24 primary endpoint analysis)

Eligibility criteria:
inclusion criteria: * plasma hiv-1 rna ≥ 1000 copies/ml at screening * treatment experience with antiretroviral therapies (excluding integrase inhibitors) * screening phenosense entry indicating bms-626529 inhibitory concentration (ic)50 \< 0.1 μm * cluster of differentiation (cd)4+ t-cell count \> 50 cells/mm3 exclusion criteria: * history (or evidence at screening) of genotypic resistance to any component of the study regimen \[ tenofovir disoproxil fumarate (tdf), atazanavir (atv), raltegravir (ral)\] * certain laboratory and electrocardiogram (ecg) values
cohort study of blood biomarkers for tes

Conditions: Chronic Traumatic Encephalopathy; Traumatic Encephalopathy, Chronic; Traumatic; Encephalopathy, Postcontusional

Summary: in this study, high-throughput screening and multi-omics (transcriptomics and proteomics) joint analysis technology will be employed to explore potential cte/tes biomarkers (rna and protein) in blood and its exosomes. thereafter, these biomarkers will be combined with the reported tbi biomarkers to create a novel set of cte/tes molecular diagnostic signatures. the findings may open a new avenue for the clinical diagnosis of the disease and the future research on its therapeutic strategy.


Eligibility criteria:
inclusion criteria: 1. athletes and patients with traumatic brain injury * age ≥ 18 and ≤ 80 years old with independent behavior ability or authorized legal representative. * have a clear history of repetitive mild tbi, concussion or subconcussion. * the most recent head injury occurred 3 months ago. 2. healthy volunteers * age ≥ 18 and ≤ 80 years old with independent behavior ability. * no history of repetitive mild tbi, concussion or subconcussion. * fully understands the nature of the study, and voluntarily participates and signs the informed consent. exclusion criteria: 1. athletes and patients with traumatic brain injury * pregnant or lactating women. * history of other neurological diseases. * history of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure. * have participated in clinical trials in the past four weeks. * the investigator believes that not appropriate for inclusion. 2. healthy volunteers * pregnant or lactating women. * history of tbi or other neurological diseases. * history of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure. * have participated in clinical trials in the past four weeks. * the investigator believe that not appropriate for inclusion.
supplementation with vitamin d, calcium or both on calcium absorption and bone mineral content in children with jra

Conditions: Juvenile Rheumatoid Arthritis

Summary: 2000 international units (iu) vitamin d, 1 gram (gm) calcium, or both given to children with juvenile rheumatoid arthritis (jra) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

supplementation with 2000 iu vitamin d, 1 gm calcium or both on calcium absorption and bone mineralization in children with juvenile rheumatoid arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.

Eligibility criteria:
inclusion criteria: * juvenile rheumatoid arthritis exclusion criteria: * steroid use
treatment for psychological and drug abuse problems

Conditions: Substance Use Disorders

Summary: the purpose of the study is to evaluate methods to help people in substance abuse treatment receive better psychiatric care. patients enrolled in the study will be offered three months of standard psychiatric treatment, which consists of weekly individual counseling and group counseling, as well as regular appointments with a psychiatrist. patients will be randomly assigned to standard psychiatric care or standard psychiatric care plus voucher incentives. these incentives can be earned by successfully attending all scheduled psychiatric appointments each week. the investigators expect that patients in the voucher condition will attend more psychiatric sessions, which will lead to greater reductions in psychiatric distress.

male and female opioid-dependent patients at addiction treatment services with any current psychiatric disorder (n = 100) will be randomly assigned to one of two psychiatric service conditions: 1) reinforced on-site integrated care (roic), with voucher incentives contingent on attending weekly psychiatric sessions; or 2) standard on-site integrated care (soic). participants in both conditions will receive access to the same schedule and range of psychiatric and substance abuse treatment services. participants will be assessed for 3-months post-randomization to determine rates of service utilization and adherence to psychiatric care, changes in scope and severity of psychiatric and psychosocial problems, and rates of drug use and treatment retention. positive findings would have considerable heuristic and health care policy and practice implications. the entire study, including dissemination of the major findings at a national meeting and submission of the first manuscript, is designed to be completed within 2-years.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * voluntarily seeking psychiatric treatment * meets dsm-iv criteria for opiate dependence * meets fda/csat guidelines for methadone maintenance * meets dsm-iv criteria for at least one current psychiatric disorder exclusion criteria: * pregnancy * onset or acute exacerbation of a medical illness requiring immediate and intense care * an organic mental disorder (e.g., delirium, dementia) * current participation in psychiatric care * mandatory psychiatric treatment

Keywords: psychiatric adherence voucher incentives methadone treatment
education interventions for self-management of pain post-sci: a pilot study

Conditions: Spinal Cord Injury; Chronic Pain

Summary: chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (sci). unfortunately, chronic pain is very difficult to treat. many treatments reduce chronic pain only partially. as a result, many people with sci must find ways of accomplishing daily activities even though they have pain. the purpose of this research study is to determine how well two different kinds of education programs reduce the extent to which chronic pain interferes with daily life and well-being.

pain is a highly prevalent and disabling condition among persons with spinal cord injury (sci). unfortunately, current pain treatments offer incomplete relief, produce side effects, and/or involve significant cost. low-risk, low-cost treatments capable of addressing residual pain and pain-related disability are greatly needed. a number of research studies have associated educational interventions with improvements in pain-related outcomes. the overall goal of the proposed pilot study is to evaluate the feasibility, acceptability, and potential benefits of two types of educational programs for people with chronic pain and spinal cord injury. this study aims to identify a low-cost, low-risk treatment option that empowers people with pain and sci to improve their functioning and quality of life.

Eligibility criteria:
inclusion criteria: * spinal cord injury for at least one year * chronic pain for at least three months that is moderate to severe (rated at or above 4/10 on a scale of 0 to 10 where 0 = "no pain" and 10 = "pain as bad as you can imagine") * fluent in english * not currently starting a new pain treatment or changing a previous pain treatment exclusion criteria: * cancer or conditions that may worsen over time (such as multiple sclerosis, parkinson disease, alzheimer's disease) and may affect my physical or mental functioning * significant difficulties with learning or memory * previous participation in a health and function education program specifically designed for people with chronic pain and sci * inability to understand english * presence of other conditions not related to sci that cause pain (such as fibromyalgia)

Keywords: spinal cord injury chronic pain education
education program to promote female condom use

Conditions: HIV Infections

Summary: the female condom offers women a potentially important option for hiv prevention. this study will develop and evaluate a health education program to increase female condom use among ethnically diverse women.

aids incidence among women has grown at alarming rates since 1985. heterosexual contact is now the greatest risk for hiv infection in women. women in the united states urgently need more options to protect themselves against hiv. nonetheless, limited prevention efforts have targeted women. the female condom is a potentially important option for hiv prevention in women. however, little research has been conducted to identify effective approaches to promote the female condom as the only female-controlled barrier method available to date. this study will develop a theoretically and empirically based intervention to increase female condom use among ethnically diverse women who engage in multiple sexual partnerships. the proposed female condom skills training intervention applies social cognitive theory. it also incorporates our extensive previous research that examined female condom acceptability and identified the attitudinal, interpersonal, and sociocultural factors affecting female condom use. the intervention consists of four sessions: 1) individual safer sex education and condom use skills training; 2) group discussion of barriers to female condom use; 3) group condom negotiation skills training; and 4) individual condom use counseling. the efficacy of the intervention will be assessed by comparing it to a control condition intervention that focuses on women's general health issues unrelated to hiv/aids. the control condition intervention has four sessions: 1) individual health education; 2) group discussion of women's health problems and related risk behaviors; 3) group discussion of healthy living; and 4) individual health risk reduction counseling. this study will use a randomized clinical trial design. study participants will be randomly assigned to one of two conditions: female condom skills training or women's general health promotion. all participants will be interviewed at study entry, 3 months, and 6 months. attitudinal, psychosexual, and behavioral data will be collected to evaluate the intervention.

Eligibility criteria:
inclusion criteria * african american, asian american, latina, or white * two or more male sexual partners in the year prior to study entry * english speaking exclusion criteria * commercial sex workers * planning to move within 6 months of study entry * allergic to polyurethane, latex, or lubricants

Keywords: female condom use male condom use aids education aids prevention hiv seronegativity
multidisciplinary program based in high intensity interval training and dietary education for coronary artery disease

Conditions: Coronary Artery Disease

Summary: a multidisciplinary program based on physiotherapy and diet education will be carried out for 3 months in patients with coronary artery disease with percutaneous coronary intervention. educational lectures on nutrition and high intensity interval training will be developed in old patients with chronic heart disease. a control group will not develop any program. effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.

a multidisciplinary program based on high intensity interval training and diet education will be carried out for 3 months for patients with coronary artery disease with percutaneous coronary intervention. three educational lectures on nutrition and a 3-month high intensity interval training will be developed in old patients with chronic heart disease. a control group will not develop any program. effectiveness on anthropometric parameters, eating habits, physical activity, quality of life, anxiety and depression will be assessed at baseline and at 3 months.

Eligibility criteria:
inclusion criteria: * infarction or angina pectoris. * at least six months elapsed since the diagnosis of heart disease at the time of the start of the study. * be physically and cognitively able to complete the evaluations and the program. exclusion criteria: * present another type of cardiac disease different from ischemic heart disease. * present any physical or psychiatric condition that prevents the normal performance of the evaluations and the program. * mobility problems to attend reassessments.
proof-of-concept, calcium aluminosilicate anti-diarrheal (casad) for treatment of clostridium difficile infection

Conditions: Diarrhoea, Clostridium Difficile

Summary: clostridium difficile (c. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. illness from c. difficile most commonly affects patients in hospitals and long-term care facilities and typically occurs after a patient has received antibiotics. in vitro data indicate calcium aluminosilicate anti-diarrheal (casad) has the potential to bind tnfα, il-1, il-6, and il-10 in the intestines and, therefore, may act to reduce severity of fever, leukocytosis, and bowel injury in patients with c. difficile infection. this would likely occur in conjunction with neutralization of c. difficile toxins a\&b by casad. computer modeling of casad performed by phillips et al. at texas a\&m university supports this hypothesis. the investigators hypothesize that adding casad 1.5 grams po tid to any standard-of-care therapy will reduce the duration and severity of diarrhea and other symptoms in patients with c. difficile infection.


Eligibility criteria:
inclusion criteria: * c. difficile-associated diarrhea at the time of enrollment * 18 years old and up * ability to take oral medications * negative urine pregnancy test for women of childbearing age * must have the ability to understand and the willingness to provide a written informed consent to participate in the study exclusion criteria: * history of known allergy to silicates * patients with signs of toxic megacolon, peritonitis, pseudomembranous colitis or bowel perforation * patients with hypotension (systolic blood pressure \< 90 mm hg) or septic shock requiring pressors * patients with other known causes of diarrhea or colitis * pregnancy or lactation * history of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up * participation in any other study where the subject is actively taking investigational medication within the last 30 days * more than 5 doses of metronidazole or oral vancomycin prior to starting on study drug for the current c. difficile diagnosis. administration of metronidazole or oral vancomycin for treatment of prior c. difficile diagnosis is not exclusionary as some patients may be experiencing a relapse of c. difficile. * any other antibiotic, toxin-binding agent or fecal transplant used for the treatment of c. difficile prior to or added to the subject's standard-of-care treatment regimen. use of intravenous vancomycin is not exclusionary.

Keywords: clostridium difficile infection diarrhea cramping
a study of the comparable efficacy and safety of pulmozyme (dornase alfa) delivered by the erapid nebulizer system in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this phase iv, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of pulmozyme (dornase alfa) delivered by the erapid nebulizer system in patients with cystic fibrosis. patients who have been receiving pulmozyme once daily chronically for at least 6 months will continue to receive pulmozyme once daily for a run-in period of 2 weeks using the pari lc plus nebulizer. patients will then be randomized to receive in a crossover design pulmozyme once daily for two treatment periods of 2 weeks each using either the pari lc plus or the erapid nebulizer. anticipated time on study treatment is 6 weeks.


Eligibility criteria:
inclusion criteria: * male and female patients, \>/= 6 years of age * confirmed diagnosis of cystic fibrosis (cf) * receiving pulmozyme once daily chronically for treatment of cf for at least 6 months prior to screening * percent predicted fev1 \>/= 40% at screening based on the wang (males \ /= 18 years, females \>/= 16 years) standardized equations * able to reproducibly perform spirometry testing and comply with study assessments exclusion criteria: * an acute respiratory infection or pulmonary exacerbation within 4 weeks prior to randomization * initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory disease within 4 weeks prior to randomization * changes in chest physiotherapy schedule within 4 weeks prior to randomization * hospitalization within 4 weeks prior to randomization * planned hospitalization during the 6-week study * history of organ transplantation * participation in an investigational drug or device study within 30 day prior to screening
efficacy of reslizumab dose escalation in patients with severe asthma

Conditions: Asthma; Eosinophilic

Summary: dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.

monoclonal antibody therapies targeting the interleukin-5 (il-5) pathway, critical for maintaining eosinophil homeostasis, have been developed as adjunct therapy for severe asthma with an eosinophilic phenotype. reslizumab/cinqair is an approved/marketed product administered monthly by intravenous to severe eosinophilic asthmatics at 3mg/kg. however some patients do exhibit sputum eosinophilia at this dosage. we are investigating whether those that receive 3mg/kg that have persistent sputum eosinophils would benefit at a higher dose of 4mg/kg and those that still exhibit sputum eosinophils at this elevated dose would show improvement at 5mg/kg. the overall aim of this study is to determine whether dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.

Eligibility criteria:
inclusion criteria: 1. asthma confirmed within the past 2 years by: a. a ≥12% improvement in forced expiratory volume in 1 second (fev1) after use of a beta agonist, or a methacholine challenge test showing a ≥20% reduction in fev1 after a concentration of ≤8 mg/ml of methacholine 2. blood eosinophils ≥400 cells/µl and/or sputum eosinophils ≥3% (or presence of moderate-to-many free eosinophil granules) at the time of study enrollment 3. treated with an inhaled corticosteroid at a dose of ≥1500 µg of fluticasone propionate (or equivalent) and a long-acting beta agonist with or without oral corticosteroids 4. ability to provide informed consent exclusion criteria: 1. current smokers, ex-smokers with greater than 20 pack-year history or ex-smokers who have smoked within the past 6 months 2. any comorbidity that the investigator believes is a contraindication including but not limited to any respiratory (e.g., chronic obstructive pulmonary disease, allergic bronchopulmonary aspergillosis, pulmonary fibrosis), cardiovascular (e.g., congestive cardiac failure, pulmonary hypertension), hematological, gastrointestinal, immunological, musculoskeletal, infectious, or neoplastic disease 3. currently treated with another biologic agent (excluding denosumab for osteoporosis) 4. use of anti-il-5 (other than reslizumab) or anti-ige mab use within the past one month 5. use of a systemic immunosuppressive or immunomodulatory agent within 6 months prior to study entry 6. suspected of abusing drugs or alcohol 7. pregnancy or lactation

Keywords: asthma eosinophilic bronchitis reslizumab